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一项针对重症监护幸存者的基于网络的康复计划(ICUTogether):一项随机对照试验的方案

A Web-Based Recovery Program (ICUTogether) for Intensive Care Survivors: Protocol for a Randomized Controlled Trial.

作者信息

Ewens Beverley, Myers Helen, Whitehead Lisa, Seaman Karla, Sundin Deborah, Hendricks Joyce

机构信息

School of Nursing and Midwifery, Edith Cowan University, Joondalup, Australia.

School of Nursing, Midwifery and Social Science, CQUniveristy Australia, Brisbane, Australia.

出版信息

JMIR Res Protoc. 2019 Jan 17;8(1):e10935. doi: 10.2196/10935.

DOI:10.2196/10935
PMID:30664478
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6354195/
Abstract

BACKGROUND

Those who experience a critical illness or condition requiring admission to an intensive care unit (ICU) frequently experience physical and psychological complications as a direct result of their critical illness or condition and ICU experience. Complications, if left untreated, can affect the quality of life of survivors and impact health care resources. Explorations of potential interventions to reduce the negative impact of an ICU experience have failed to establish an evidence-based intervention.

OBJECTIVE

The aim of this study is to evaluate the impact of a Web-based intensive care recovery program on the mental well-being of intensive care survivors and to determine if it is a cost-effective approach.

METHODS

In total, 162 patients that survived an ICU experience will be recruited and randomized into 1 of 2 groups. The intervention group will receive access to the Web-based intensive care recovery program, ICUTogether, 2 weeks after discharge (n=81), and the control group will receive usual care (n=81). Mental well-being will be measured using the Hospital Anxiety and Depression Scale, The Impact of Events Scale-Revised and the 5-level 5-dimension EuroQoL at 3 time points (2 weeks, 6 months, and 12 months post discharge). Family support will be measured using the Multidimensional Scale of Perceived Social Support at 3 time points. Analysis will be conducted on an intention-to-treat basis using regression modeling. Covariates will include baseline outcome measures, study allocation (intervention or control), age, gender, length of ICU stay, APACHE III score, level of family support, and hospital readmissions. Participants' evaluation of the mobile website will be sought at 12 months postdischarge. A cost utility analysis conducted at 12 months from a societal perspective will consider costs incurred by individuals as well as health care providers.

RESULTS

Participant recruitment is currently underway. Recruitment is anticipated to be completed by December 2020.

CONCLUSIONS

This study will evaluate a novel intervention in a group of ICU survivors. The findings from this study will inform a larger study and wider debate about an appropriate intervention in this population.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10935.

摘要

背景

那些经历严重疾病或状况而需要入住重症监护病房(ICU)的人,常常会因其严重疾病或状况以及ICU经历而直接出现身体和心理并发症。如果不加以治疗,这些并发症会影响幸存者的生活质量,并影响医疗资源。对减少ICU经历负面影响的潜在干预措施的探索未能确立基于证据的干预措施。

目的

本研究的目的是评估基于网络的重症监护康复计划对重症监护幸存者心理健康的影响,并确定其是否具有成本效益。

方法

总共将招募162名经历过ICU治疗并存活的患者,并随机分为两组。干预组将在出院后2周(n = 81)获得基于网络的重症监护康复计划ICUTogether,对照组将接受常规护理(n = 81)。将在3个时间点(出院后2周、6个月和12个月)使用医院焦虑抑郁量表、事件影响量表修订版和5级5维度欧洲五维健康量表来测量心理健康状况。将在3个时间点使用多维感知社会支持量表来测量家庭支持情况。将使用回归模型在意向性分析的基础上进行分析。协变量将包括基线结局指标、研究分组(干预组或对照组)、年龄、性别、ICU住院时间、急性生理与慢性健康状况评分系统III(APACHE III)评分、家庭支持水平和再次入院情况。将在出院后12个月征求参与者对移动网站的评价。从社会角度在12个月时进行的成本效用分析将考虑个人以及医疗服务提供者产生的成本。

结果

目前正在招募参与者。预计招募工作将于2020年12月完成。

结论

本研究将评估针对一组ICU幸存者的新型干预措施。本研究的结果将为关于该人群适当干预措施的更大规模研究和更广泛辩论提供信息。

国际注册报告识别码(IRRID):PRR1-10.2196/10935

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f12a/6354195/cf5a8f0476d8/resprot_v8i1e10935_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f12a/6354195/cf5a8f0476d8/resprot_v8i1e10935_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f12a/6354195/cf5a8f0476d8/resprot_v8i1e10935_fig1.jpg

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